ISO 22716: 2007 化妆品良好生产规范 中英文对照（生产）

官方英文版：

https://www.iso.org/standard/36437.html

官方中文版：

https://std.samr.gov.cn/hb/search/stdHBDetailed?id=8B1827F1C68ABB19E05397BE0A0AB44A

Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices

化妆品良好生产规范

7 Production 生产

7.1 Principle 原则

At each stage of manufacturing operations and packaging operations, measures should be taken to produce a finished product that meets the defined characteristics.

在制造和包装过程的不同阶段，应采取措施确保所生产的成品符合规定特性。

7.2 Manufacturing operations 制造过程

7.2.1 Availability of relevant documents 获取相关文件

7.2.1.1 Relevant documentation should be available at each stage of manufacturing operations. 

制造过程每个阶段都应能获取适当的相关文件。

7.2.1.2 Manufacturing operations should be carried out according to manufacturing documentation, including:

制造过程应根据相关的文件执行，包括：

a) suitable equipment; 

适当的设备；

b) formula for the product; 

产品配方；

c) list of all raw materials identified according to relevant documents indicating batch numbers and quantities; 

文件规定的原料清单，并载明批号和数量；

d) detailed manufacturing operations for each stage, such as addition of raw materials, temperatures, speeds, mixing times, sampling, cleaning and, if necessary, sanitizing of equipment, and bulk product transfer. 

制造过程各阶段的详细操作，如投料、温度、速度、混合时间、抽样、设备的清洁及必要的消毒、半成品的转移。

7.2.2 Start-up checks 启动检查

Before starting any manufacturing operations, it should be ensured that: 

开始制造过程前，应确保：

a) all documentation relevant to the manufacturing operations is available; 

制造过程所有的相关文件已准备；

b) all raw materials are available and released; 

所有原料齐备并经放行；

c) suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized; 

适用的设备到位并处于正常工作状态。设备已进行清洁及必要的消毒；

d) clearance of the area has been performed to avoid mixing with materials from previous operations. 

场地已进行清理，以避免与前次生产的物料混淆。

7.2.3 Assignment of a batch number 批号分配

A batch number should be assigned to each batch of manufactured bulk product. This number does not need to be identical with the batch number that appears on the label of the finished product, but, if not, it should be easy to relate to that number.

每批半成品应有批号加以识别。该批号与成品标签上的批号不一定需要一致，但如不一致，应易于对应。

7.2.4 Identification of in-process operations 过程操作的标识

7.2.4.1 In accordance with the formula, all raw materials should be measured or weighed, into clean and suitable containers labelled with appropriate identification or directly into the equipment used for manufacturing. 

所有原料应根据配方称量，盛放于适当标识的清洁容器中，或直接置于制造设备中。

7.2.4.2 At all times, it should be possible to identify major equipment, containers of raw materials and containers of bulk products. 

主要设备、盛放原料和半成品的容器在任何时候均应有标识。

7.2.4.3 Identification of containers of bulk products should indicate: 

半成品容器的标识应载明：

a) name or identifying code; 

名称或代码；

b) batch number; 

批号；

c) storage conditions when such information is critical to assure the quality of the product. 

与产品质量密切相关的储存条件。

7.2.5 In-process control 过程控制

7.2.5.1 In-process controls and their acceptance criteria should be defined.

应规定过程控制及其接收标准。

7.2.5.2 In-process controls should be performed according to a defined programme. 

应按照规定程序进行过程控制。

7.2.5.3 Any result outside the acceptance criteria should be reported and appropriately investigated.

应报告不符合接收标准的结果并做适当的调查。

7.2.6 Bulk product storage 半成品储存

7.2.6.1 Bulk product should be stored in suitable containers, in defined areas, and under appropriate conditions.

半成品应盛放于适当的容器里，在适宜的条件下存放于规定的区域内。

7.2.6.2 The maximum bulk product storage duration should be defined. 

应规定半成品的保存期限。

7.2.6.3 When this duration is reached, the bulk product should be re-evaluated before use.

超过保存期限的半成品使用前应再评估。

7.2.7 Re-stocking raw materials 原料退仓

If raw materials remain unused after weighing and are intended and deemed acceptable to return to stock, their containers should be closed and properly identified.

称量后不使用且被确认可以退回仓库的原料，其容器应密闭并做好标识。

7.3 Packaging operations 包装过程

7.3.1 Availability of relevant documents 获取相关文件

7.3.1.1 Relevant documentation should be available at each stage of packaging operations.

包装过程的每个阶段都应能获取适当的相关文件。

7.3.1.2 Packaging operations should be carried out according to packaging documentation including: 

包装过程应根据相关的文件执行，包括：

a) suitable equipment; 

适宜的设备；

b) list of packaging materials defined for the intended finished product; 

用于成品的包装材料清单；

c) detailed packaging operations such as filling, closing, labelling, and coding. 

包装过程各阶段的详细操作，如充填、封装、贴标签和喷码。

7.3.2 Start-up checks 启动检查

Before starting any packaging operation, it should be ensured that: 

开始包装过程前，应确保：

a) the area has been cleared of materials to avoid mixing with materials from previous operations; 

场地已进行清理，以避免与上次生产的物料混淆；

b) all documentation relevant to the packaging operations, is available; 

包装过程所有的相关文件已准备；

c) all packaging materials are available; 

所有包装材料齐备；

d) suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized; 

适用的设备到位并处于正常工作状态。设备已进行清洁和必要的消毒；

e) any coding to permit identification of the product is defined. 

已规定识别产品的代码。

7.3.3 Assignment of batch number 批号分配

7.3.3.1 A batch number should be assigned to each unit of finished product.

每件成品都应有批号。

7.3.3.2 This number does not need to be identical with the batch number that appears on the label of the bulk product, but, if not, it should be easy to relate to that number.

成品的批号与半成品标签上的批号不一定需要一致，但如不一致，应易于对应。

7.3.4 Packaging line identification 包装线标识

At all times, it should be possible to identify the packaging line with its name or identifying code, the name or identifying code of the finished product and the batch number.

任何时候包装线都能通过其名称或代码、成品的名称或代码以及批号进行识别。

7.3.5 Checks of on-line control equipment 在线控制设备的检查

If used, on-line control equipment should be regularly checked according to a defined programme. 

应按照规定程序对使用的在线控制设备定期检查。

7.3.6 In-process control 过程控制

7.3.6.1 In-process controls and their acceptance criteria should be defined. 

应规定过程控制及其接收标准。

7.3.6.2 In-process controls should be performed according to a defined programme. 

应按照规定程序进行过程控制。

7.3.6.3 Any result that is outside the acceptance criteria should be reported and appropriately investigated.

应报告不符合接收标准的结果并做适当的调查。

7.3.7 Re-stocking of packaging materials 包装材料退仓

If packaging materials remain unused after packaging operations and are intended and deemed acceptable to return to stock, their containers should be closed and properly identified. 

包装过程后未使用并被确认可以退回仓库的包装材料，其容器应密闭并做好标识。

7.3.8 Identification and handling of work-in-process 在制品的标识与处理

Filling and labelling is usually a continuous process. Where this is not the case, special measures including segregation and identification should be applied so that no mix-ups or mislabelling can occur.

充填和贴标签通常为连续过程。如不连续，应采取隔离及标识等特别措施以避免混淆或贴错标签。